Industry Resources

Compliance

Did You Know?

68%

of States in the U.S. have medical cannabis laws.

Education & Programs

Become an Industry Leader in Product Safety

The Patient Focused Certification seal of approval displayed by your business will provide medical practitioners, patients and regulators with peace of mind. And when they see the PFC they will know that your company is adhering to regulatory guidelines – committed to the purity and identity of products being sold and that your company has implanted product safety protocols for cultivation, manufacturing, distribution and lab testing of those products.

Becoming PFC certified means you will have access to some of the industry’s best technical experts, delivering consistent, personalized service with the highest levels of integrity. PFC ensures your business maintains ongoing compliance with State and local regulations by providing services and trainings that meet the regulatory requirement! With PFC behind you, your patients and their health care providers can be confident your products and processes meet the highest levels of safety and quality available.

Benefits of Certification

PFC works at the local and state level to increase awareness of the AHPA standards and the AHP Cannabis Monograph with relevant agencies. PFC and AHPA work directly with legislators, regulators and industry trade groups to encourage the adoption of AHPA’s Recommendations to Regulators and standards outlined in the AHP Cannabis Monograph. As such, regulators in the states of Alaska, Florida, New York, Illinois, Maryland, Nevada, Washington, Oregon, Massachusetts, Minnesota, Hawaii, and Colorado have adopted portions of the AHPA’s Recommendations and/or the AHP Cannabis Monograph.

As the regulatory framework for medical cannabis businesses continues to develop throughout the US, demonstrating adherence to national best-practice standards can help businesses avoid being subjected to the development of onerous state and local regulations that may challenge the ability of small businesses to be successful. Throughout history, big business, with the support of government, has used unnecessarily narrow or stringent regulations to monopolize marketplaces. Certifying your business with PFC shows regulators and lawmakers that your business has high standards of operation in accordance with other botanical products, discouraging the development of overly restrictive regulations.

Both ASA and AHPA are dedicated to the adoption of mandatory standards for the medical cannabis industry nationally. Your participation in the PFC Program helps to ensure that our outreach to your specific regulators gives your company an advantage.

In today’s regulated marketplace, failure to meet regulatory compliance can result in the denial of licensure for an applicant. Or, in the case of an established company can result in costly fines, the recall and/or confiscation of products, and suspension or termination of your company’s license. As a participant in the PFC program, your company can rest assured that PFC’s inspection auditors will identify any and all compliance issues that could jeopardize your company’s ability to maintain compliance with local and state regulations. As localities and state regulators adjust and update regulations, PFC staff will ensure that your company is aware of all upcoming regulatory changes.

Prior to the adoption of product safety guidelines in the herbal, botanical, and nutraceutical industries product liability lawsuits continually challenged the stability, growth, and future of these companies. As public concern in the US mounted over the increasing number of product liability lawsuits larger agencies such as the FDA entered into the conversation about regulations and pressures rose to restrict herbal, botanical, and nutraceutical products from public availability. However, through the voluntary adoption of rigorous product safety guidelines, the herbal, botanical and nutraceutical industry was able to ease the concerns of both the public and regulatory agencies allowing the industry to stabilize and avoid overly onerous FDA regulations.

Today, the medical cannabis and adult use industry find themselves in a very similar situation. As medical cannabis and adult use laws have been implemented throughout the US, product safety has been an afterthought in many of these laws and rule making processes. By working with PFC to adopt nationally recognized product safety standards, you directly reduce your company’s service and product liability. Through proper lot and batch number tracking, health and hygiene protocols, standardized testing, proper labeling, as well as adverse event reporting and recall strategies cannabis businesses who wear the PFC seal of approval raise the bar of product safety to that of the herbal, botanical, and nutraceutical industry in the US.

PFC certification helps your company identify, develop and address product safety protocols before a product safety liability issue can arise. Engaging in the PFC program costs the average company less than 1% of their annual revenue whereas product liability lawsuits often cost companies hundreds of thousands of dollars. Let PFC help your company develop a solid foundation of product safety and avoid costly product liability lawsuits that often irreparably damage businesses or close them all together.

The PFC seal displayed by cannabis businesses and on cannabis/hemp products provides medical practitioners, patients, and regulators with peace of mind that your company is adhering to regulatory guidelines. The seal also shows that your company is committed to the purity and identity of products being sold, has implemented lot and batch number tracking protocols including an operations product recall plan, and has implemented standardized methods for the cultivation, manufacturing, distribution, and lab testing of those products.

Additionally our outreach programs educate patients, their caregivers, and medical professionals to look for PFC certified products so that they can choose their medicine with confidence, knowing that it was produced in a manner that provides consistent results and protects consumer safety. PFC’s advertising and marketing prominently features our certified companies and includes both traditional industry publications and unique channels, such as Complementary and Alternative Medicine outlets.

As medical cannabis, adult use, and hemp businesses have emerged in the legal marketplace , state and local lawmakers have created a patchwork of laws and regulations. Almost all companies entering into the PFC program will find that some form of corrective action is necessary to achieve and maintain certification. Let PFC help your company achieve excellence in compliance, Best Business Practices, quality of care, and product safety.

Due to the ever-changing and expanding nature of medical cannabis regulations and medical cannabis industry innovations, PFC recognizes the need to continually review and adopt new standards and guidelines that reflect regulatory changes. For this reason the PFC Program has been developed as a continually evolving program overseen by a Peer Review Board which along with AHPA and AHP act to oversee the ongoing update of PFC program standards. Depending on the extent of standard updates approved by the PFC Peer Review Board, a PFC auditor may be assigned to the affected certified companies in order to verify that all necessary compliance updates have taken place. Additional staff training may also be required. The addition of program requirements, determination of corrective actions, and need for additional trainings, are all determined by the PFC Peer Review Board.

PFC operates an independent complaint hotline that provides patients, consumers, and caregivers the means to report a concern, complaint, or adverse event relating to a service or product. If a verified third-party complaint is recorded and it is determined to require an investigation or a large number of complaints are lodged against a specific certified service or product, a review audit may be necessary. PFC will evaluate and respond to all third-party complaints verifying the legitimacy and severity of the complaint, and when necessary, require immediate corrective action. Certified companies are required to respond to complaint inquiries within five (5) business days of notification by an assigned PFC auditor or staff person.

When filing a complaint, a Complaint Investigation Request provided by PFC and available online, must be completed and signed by the complaining party. Complaints will be sent directly to the Program Director, who will track all complaints and investigations. PFC will acknowledge receipt of the complaint, promptly investigate and validate the complaint, and take appropriate actions. PFC shall ensure the proper corrective actions have been implemented and notify the complainant of such actions. The certified company will be advised of the complaint at the appropriate time during the investigation. PFC shall determine, together with the certified company and complainant (and regulators where necessary), if the complaint and resolution should be made public.

When a complaint is made by a company, whether PFC certified or not, the complainant agrees to bear the cost of an investigation if the complaint is not verified. If the complaint is substantiated, the certified company shall be responsible for all costs of the investigation. Regulatory authorities, individual consumers, and licensed health care providers are exempt from bearing the costs of any investigation costs. PFC shall not identify the complainant unless required to do so by law. If a complainant does not sign a Complaint Investigation Request, PFC will consider it an informal complaint and will investigate as needed but has no obligation to investigate or respond.

Industry Program Guide

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